FDA Orange Book
Generic for Combivir
Combivir contains lamivudine and zidovudine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Combivir is lamivudine and zidovudine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Combivir products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;300MG | Discontinued | None | 6 | AB |
NDA 020857, held by VIIV HEALTHCARE CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lamivudine and zidovudine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HETERO LABS LTD UNIT V | 203259 | AB (A-rated, therapeutically equivalent) | February 3, 2014 | 150MG;300MG |
| HETERO LABS LTD UNIT III | 079124 | AB (A-rated, therapeutically equivalent) | September 17, 2015 | 150MG;300MG |
| AUROBINDO PHARMA LTD | 077558 | AB (A-rated, therapeutically equivalent) | May 5, 2017 | 150MG;300MG |
| EPIC PHARMA LLC | 206375 | AB (A-rated, therapeutically equivalent) | April 10, 2018 | 150MG;300MG |
| MACLEODS PHARMACEUTICALS LTD | 090679 | AB (A-rated, therapeutically equivalent) | August 29, 2018 | 150MG;300MG |
| CIPLA LTD | 077411 | AB (A-rated, therapeutically equivalent) | September 7, 2018 | 150MG;300MG |
Combivir NDC codes
Questions
Is there a generic for Combivir?
Yes. The generic name for Combivir is lamivudine and zidovudine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Combivir?
The active ingredient in Combivir is lamivudine and zidovudine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
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